Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02229227
• Collaborator: PPD (Industry)
• Enrollment: 814
• Locations: 158
• Arms: 2
• Actual Duration (Months): 32.1
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Albiglutide; Drug: Insulin Glargine and Insulin Lispro	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 814 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study
• Actual Study Start Date: Nov 21, 2014
• Actual Primary Completion Date: Jul 24, 2017
• Actual Study Completion Date: Jul 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albiglutide + Insulin Glargine Arm During standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will receive Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection and insulin lispro dose will be downtitrated to half that used in the standardization period. At Week 4, Albiglutide will be uptitrated to 50 mg weekly SC injection and insulin lispro will be stopped for the remainder of the treatment Period. Insulin lispro may be re-introduced after Week 8 according to pre-defined hyperglycemia thresholds. Insulin will be adjusted according to protocol-defined insulin titration algorithms	Drug: Albiglutide; Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector
Experimental: Insulin Glargine + Insulin Lispro Arm During standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will continue with the same doses as at the end of the standardization period and doses will be adjusted according to protocol-defined insulin titration algorithms	Drug: Insulin Glargine and Insulin Lispro; Insulin glargine and insulin lispro will be provided as injection pens for SC injection

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [Baseline (Day -1) and Week 26]

   HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

Secondary Outcome Measures

1. Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26 [Up to Week 26]

   Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.

2. Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26 [Up to Week 26]

   Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).

3. Change From Baseline in Body Weight at Week 26 [Baseline (Day -1) and Week 26]

   Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

4. Change From Baseline to Week 26 in Body Weight [Baseline (Day -1) to Week 26]

   Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

5. Total Daily Insulin Dose at Week 26 [Week 26]

   Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.

6. Change From Baseline to Week 26 in HbA1c [Baseline to Week 26]

   HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

7. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [Baseline and Week 26]

   FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

8. Change From Baseline to Week 26 in FPG [Baseline to Week 26]

   FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

9. Number of Participants Achieving HbA1c <7.0% at Week 26 [Week 26]

   HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.

10. Number of Participants Achieving HbA1c <7.0% up to Week 26 [Up to Week 26]

    HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.

11. Number of Participants Achieving a HbA1c <6.5% at Week 26 [Week 26]

    Number of participants achieving a HbA1c <6.5% at Week 26 are presented.

12. Number of Participants Achieving a HbA1c <6.5% up to Week 26 [Up to Week 26]

    Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.

13. Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26 [Week 26]

    Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.

14. Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 [Up to Week 26]

    Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.

15. Total Daily Insulin Dose at Week 4, Week 10 and Week 18 [Weeks 4, 10, and 18]

    Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

16. Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits [Weeks 4, 10, 18, and 26]

    Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

17. Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits [Weeks 4, 10, 18, and 26]

    Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

18. Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 [Baseline (Day -1) and Weeks 4, 10, 18 and 26]

    Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.

19. Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26 [Week 26]

    Percentage of participants achieving HbA1c <7.0% without weight gain are presented.

20. Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26 [Week 26]

    Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.

21. Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26 [Week 26]

    Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.

22. Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication [Up to Week 26]

    AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.

23. Number of Participants With Other AE of Special Interest [Up to Week 26]

    AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.

24. Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 [Up to Week 26]

    Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.

25. Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) [Up to Week 26]

    The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.

26. Number of Participants With Daytime and Nocturnal Hypoglycemia [Up to Week 26]

    Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.

27. Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms [Up to Week 26]

    Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.

28. Number of Participants With Hematology Values of Clinical Concern [Up to 30 weeks]

    Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.

29. Number of Participants With Clinical Chemistry Values of Clinical Concern [Up to 30 weeks]

    Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.

30. Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26 [Week 0 and Week 26]

    Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.

31. Mean Albumin at Week 0 and Week 26 [Week 0 and Week 26]

    Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.

32. Mean Creatinine at Week 0 and Week 26 [Week 0 and Week 26]

    Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.

33. Mean Specific Gravity at Week 0 and Week 26 [Week 0 and Week 26]

    Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

34. Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 [Week 0 and Week 26]

    Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

35. Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 [Week 0 and Week 26]

    Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.

36. Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 [Week 0 and Week 26]

    Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.

37. Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 [Baseline, Week 10 and Week 26]

    Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

38. Number of Participants With Vital Signs of Clinical Concern [Up to 30 weeks]

    Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.

39. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters [Up to 30 weeks]

    A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM

• HbA1c >= 7.0% and <= 9.0% at Screening.

• Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following:

• Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND

• Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro) with a total daily dose of bolus insulin <= 70 units

• In addition, the total daily dose of insulin must be <= 140 units

• If taking metformin, a stable dose for at least 8 weeks before Screening Note: Subject should not have received any other antidiabetic medication within 30 days before screening (e.g., glucagon-like peptide-1 receptor (GLP-1R) agonist, dipeptidyl peptidase-IV inhibitor, SU, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.

• Fasting C-peptide >= 0.8 nanogram (ng) per milliliter (mL) [>= 0.26 nanomoles per litre (nmol/L)]

• Body mass index <= 40 kilogram per square meter( kg/m^2)

• Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4)

• Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week post treatment Follow-up Period..

• Willing and able to comply with all study procedures including performance of frequent self-monitored blood glucose (SMBG) profiles according to the protocol

• Able and willing to provide written informed consent

Exclusion Criteria:

• Type 1 diabetes mellitus

• History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

• Current symptomatic biliary disease or history of acute or chronic pancreatitis

• Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening

• History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function [e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function]

• History of severe hypoglycemia unawareness

• Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product

• Clinically significant CV and/or cerebrovascular disease within 3 months before

Screening including, but not limited to, the following:

• Stroke or transient ischemic attack

• Acute coronary syndrome (myocardial infarction [MI] or unstable angina not responsive to nitroglycerin)

• Cardiac surgery or percutaneous coronary procedure

• Current or history of heart failure (New York Heart Association class III or IV)

• Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment [e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening])

• Hemoglobin <11 gram (g) per (dL) [<110 g/L] for male subjects and <10 g/dL (<100 g/L) for female subjects at Screening

• Estimated glomerular filtration rate (eGFR) <= 30 millilitre per minute per 1.73 square meters (mL/min/1.73 m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at Screening Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.

• Fasting triglyceride level >750 mg/dL at Screening

• Hemoglobinopathy that may affect proper interpretation of HbA1c

• Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., insulin glargine, insulin lispro)

• Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed

• Female subject is pregnant (confirmed by laboratory testing) or lactating

• Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Searcy	Arkansas	United States	72143
2	GSK Investigational Site	Huntington Beach	California	United States	92648
3	GSK Investigational Site	Long Beach	California	United States	90807
4	GSK Investigational Site	Los Angeles	California	United States	90017
5	GSK Investigational Site	Tustin	California	United States	92780
6	GSK Investigational Site	West Hills	California	United States	91307
7	GSK Investigational Site	Colorado Springs	Colorado	United States	80909
8	GSK Investigational Site	Brooksville	Florida	United States	34601
9	GSK Investigational Site	Clearwater	Florida	United States	33765
10	GSK Investigational Site	Hialeah	Florida	United States	33012
11	GSK Investigational Site	Miami	Florida	United States	33156
12	GSK Investigational Site	Orlando	Florida	United States	32825
13	GSK Investigational Site	Pembroke Pines	Florida	United States	33027
14	GSK Investigational Site	Tampa	Florida	United States	33634
15	GSK Investigational Site	West Palm Beach	Florida	United States	33401
16	GSK Investigational Site	Chicago	Illinois	United States	60612
17	GSK Investigational Site	Paducah	Kentucky	United States	42003
18	GSK Investigational Site	Lake Charles	Louisiana	United States	70601
19	GSK Investigational Site	Shreveport	Louisiana	United States	71105
20	GSK Investigational Site	Kalamazoo	Michigan	United States	49009
21	GSK Investigational Site	Springfield	Missouri	United States	65807
22	GSK Investigational Site	Las Vegas	Nevada	United States	89119
23	GSK Investigational Site	Staten Island	New York	United States	10301
24	GSK Investigational Site	Shelby	North Carolina	United States	28150
25	GSK Investigational Site	Wilmington	North Carolina	United States	28401
26	GSK Investigational Site	Columbus	Ohio	United States	43213
27	GSK Investigational Site	Dayton	Ohio	United States	45439
28	GSK Investigational Site	Kettering	Ohio	United States	45429
29	GSK Investigational Site	Austin	Texas	United States	78749
30	GSK Investigational Site	Austin	Texas	United States	78756
31	GSK Investigational Site	Dallas	Texas	United States	75230
32	GSK Investigational Site	Houston	Texas	United States	77058
33	GSK Investigational Site	Houston	Texas	United States	77099
34	GSK Investigational Site	Pharr	Texas	United States	78577
35	GSK Investigational Site	Round Rock	Texas	United States	78681
36	GSK Investigational Site	Sugar Land	Texas	United States	77479
37	GSK Investigational Site	Hampton	Virginia	United States	23666
38	GSK Investigational Site	Renton	Washington	United States	98057
39	GSK Investigational Site	Tacoma	Washington	United States	98405
40	GSK Investigational Site	Fortaleza - CE	Ceará	Brazil	60430-350
41	GSK Investigational Site	Fortaleza	Ceará	Brazil	60115-282
42	GSK Investigational Site	Goiânia	Goiás	Brazil	74110-010
43	GSK Investigational Site	Uberlandia	Minas Gerais	Brazil	38411-186
44	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035-170
45	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035001
46	GSK Investigational Site	Campinas	São Paulo	Brazil	13010-001
47	GSK Investigational Site	Marília	São Paulo	Brazil	17519-000
48	GSK Investigational Site	Pará		Brazil	66073-000
49	GSK Investigational Site	São Paulo		Brazil	01223-001
50	GSK Investigational Site	São Paulo		Brazil	04038-002
51	GSK Investigational Site	Penticton	British Columbia	Canada	V2A 5C8
52	GSK Investigational Site	Brampton	Ontario	Canada	L6S 0C9
53	GSK Investigational Site	Oakville	Ontario	Canada	L6M 1M1
54	GSK Investigational Site	Thornhill	Ontario	Canada	L4J 8L7
55	GSK Investigational Site	Toronto	Ontario	Canada	M4G 3E8
56	GSK Investigational Site	Saint Laurent	Quebec	Canada	H4T 1Z9
57	GSK Investigational Site	Corbeil-Essonnes		France	91106
58	GSK Investigational Site	Nantes Cedex 1		France	44093
59	GSK Investigational Site	Valenciennes		France	59322
60	GSK Investigational Site	Vandoeuvre les Nancy		France	54501
61	GSK Investigational Site	Venissieux		France	69200
62	GSK Investigational Site	Bad Mergentheim	Baden-Wuerttemberg	Germany	97980
63	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69115
64	GSK Investigational Site	Wangen	Baden-Wuerttemberg	Germany	88239
65	GSK Investigational Site	Aschaffenburg	Bayern	Germany	63739
66	GSK Investigational Site	Sulzbach-Rosenberg	Bayern	Germany	92237
67	GSK Investigational Site	Asslar	Hessen	Germany	35614
68	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern	Germany	19059
69	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45355
70	GSK Investigational Site	Ludwigshafen am Rhein	Rheinland-Pfalz	Germany	67059
71	GSK Investigational Site	Rhaunen	Rheinland-Pfalz	Germany	55624
72	GSK Investigational Site	Saarlouis	Saarland	Germany	66740
73	GSK Investigational Site	Sankt Ingbert	Saarland	Germany	66386
74	GSK Investigational Site	Dresden	Sachsen	Germany	01307
75	GSK Investigational Site	Pirna	Sachsen	Germany	01796
76	GSK Investigational Site	Berlin		Germany	10115
77	GSK Investigational Site	Baja		Hungary	6500
78	GSK Investigational Site	Balatonfured		Hungary	8230
79	GSK Investigational Site	Budapest		Hungary	1036
80	GSK Investigational Site	Budapest		Hungary	1158
81	GSK Investigational Site	Budaörs		Hungary	2040
82	GSK Investigational Site	Debrecen		Hungary	4031
83	GSK Investigational Site	Pecs		Hungary	7643
84	GSK Investigational Site	Zalaegerszeg		Hungary	8900
85	GSK Investigational Site	Napoli	Campania	Italy	80131
86	GSK Investigational Site	Bologna	Emilia-Romagna	Italy	40138
87	GSK Investigational Site	Roma	Lazio	Italy	00128
88	GSK Investigational Site	Milano	Lombardia	Italy	20122
89	GSK Investigational Site	Milano	Lombardia	Italy	20132
90	GSK Investigational Site	Pavia	Lombardia	Italy	27100
91	GSK Investigational Site	Gyeonggido		Korea, Republic of	420-717
92	GSK Investigational Site	Seoul		Korea, Republic of	135-710
93	GSK Investigational Site	Pachuca	Hidalgo	Mexico	42084
94	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44570
95	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44657
96	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44670
97	GSK Investigational Site	Monterrey NL	Nuevo León	Mexico	64718
98	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64020
99	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64460
100	GSK Investigational Site	Merida	Yucatán	Mexico	97070
101	GSK Investigational Site	Aguascalientes		Mexico	20129
102	GSK Investigational Site	Aguascalientes		Mexico	20230
103	GSK Investigational Site	Chihuahua		Mexico	31217
104	GSK Investigational Site	Durango		Mexico	34000
105	GSK Investigational Site	Durango		Mexico	34080
106	GSK Investigational Site	Guadalajara		Mexico	44600
107	GSK Investigational Site	Mexico City		Mexico	03300
108	GSK Investigational Site	Mexico		Mexico	07760
109	GSK Investigational Site	Mexico		Mexico	14000
110	GSK Investigational Site	Veracruz		Mexico	91020
111	GSK Investigational Site	Davao City		Philippines	8000
112	GSK Investigational Site	Manila		Philippines	1000
113	GSK Investigational Site	Marikina City		Philippines	1810
114	GSK Investigational Site	Quezon City		Philippines	2000
115	GSK Investigational Site	Bialystok		Poland	15-435
116	GSK Investigational Site	Kamieniec Zabkowicki		Poland	57-230
117	GSK Investigational Site	Lodz		Poland	90-132
118	GSK Investigational Site	Oswiecim		Poland	32-600
119	GSK Investigational Site	Pulawy		Poland	24-100
120	GSK Investigational Site	Radom		Poland	26-610
121	GSK Investigational Site	Ruda Slaska		Poland	41-709
122	GSK Investigational Site	Zamosc		Poland	22-400
123	GSK Investigational Site	Bloemfontein	Free State	South Africa	9301
124	GSK Investigational Site	Johannesburg	Gauteng	South Africa	1685
125	GSK Investigational Site	Johannesburg	Gauteng	South Africa	2013
126	GSK Investigational Site	Durban	KwaZulu- Natal	South Africa	4067
127	GSK Investigational Site	Johannesburg		South Africa	2193
128	GSK Investigational Site	Krugersdorp		South Africa	1724
129	GSK Investigational Site	Worcester		South Africa	6850
130	GSK Investigational Site	Alcala de Henares		Spain	28805
131	GSK Investigational Site	Alzira/Valencia		Spain	46600
132	GSK Investigational Site	Badalona		Spain	08916
133	GSK Investigational Site	Barakaldo (Vizcaya)		Spain	48903
134	GSK Investigational Site	Barcelona		Spain	08036
135	GSK Investigational Site	Barcelona		Spain	8041
136	GSK Investigational Site	Ferrol. La Coruña		Spain	15405
137	GSK Investigational Site	Granada		Spain	18012
138	GSK Investigational Site	Granada		Spain	18014
139	GSK Investigational Site	La Coruña		Spain	15006
140	GSK Investigational Site	León		Spain	24071
141	GSK Investigational Site	Lleida		Spain	25198
142	GSK Investigational Site	Madrid		Spain	28006
143	GSK Investigational Site	Madrid		Spain	28046
144	GSK Investigational Site	Majadahonda		Spain	28220
145	GSK Investigational Site	Malaga		Spain	29010
146	GSK Investigational Site	Merida		Spain	6800
147	GSK Investigational Site	Málaga		Spain	29010
148	GSK Investigational Site	Palma de Mallorca		Spain	07120
149	GSK Investigational Site	Palma de Mallorca		Spain	07198
150	GSK Investigational Site	Pozuelo De Alarcón/Madrid		Spain	28223
151	GSK Investigational Site	Santiago de Compostela		Spain	15706
152	GSK Investigational Site	Valencia		Spain	46014
153	GSK Investigational Site	Valencia		Spain	46026
154	GSK Investigational Site	Welwyn Garden City	Hertfordshire	United Kingdom	AL7 4HQ
155	GSK Investigational Site	Bath	Somerset	United Kingdom	BA1 3NG
156	GSK Investigational Site	Hull		United Kingdom	HU3 2JZ
157	GSK Investigational Site	Lancashire		United Kingdom	BL9 7TD
158	GSK Investigational Site	Sidcup		United Kingdom	DA14 6LT

Sponsors and Collaborators

• GlaxoSmithKline
• PPD

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Sep 24, 2015
• Statistical Analysis Plan - Sep 7, 2017

More Information

Publications

• Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02229227
• Other Study ID Numbers: 200977; 2014-001821-34
• First Posted: Sep 1, 2014
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: switch study; albiglutide; glucagon-like peptide-1 receptor agonist; Type 2 diabetes mellitus; basal-bolus insulin therapy
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin Glargine; Insulin Lispro; rGLP-1 protein

Study Results

Participant Flow

Recruitment Details	This study was conducted from 21-Nov-2014 to 24-Jul-2017 at 186 centers in 14 countries: Canada, United States of America, Mexico, Brazil, Hungary, Poland, France, Germany, Italy, Spain, United Kingdom, Korea, Philippines and South Africa.
Pre-assignment Detail	A total of 2004 participants were screened, of which 973 participants were screen failures and 160 participants were re-screened. A total of 1031 participants then entered the standardization period, of which 217 participants were standardization failures. A total of 814 participants were randomized in the study.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Period Title: Overall Study
STARTED	402	412
COMPLETED	351	350
NOT COMPLETED	51	62

Baseline Characteristics

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine	Total
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.	Total of all reporting groups
Overall Participants	402	412	814
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.0 (9.40)	58.1 (9.49)	58.1 (9.44)
Sex: Female, Male (Count of Participants)
Female	228 56.7%	214 51.9%	442 54.3%
Male	174 43.3%	198 48.1%	372 45.7%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	43 10.7%	28 6.8%	71 8.7%
Asian-Central/South Asian (A) Heritage (H)	5 1.2%	8 1.9%	13 1.6%
Asian-Japanese H/East AH/South East AH	25 6.2%	24 5.8%	49 6%
Black or African American	37 9.2%	32 7.8%	69 8.5%
Native Hawaiian or Other Pacific Islander	1 0.2%	3 0.7%	4 0.5%
White	284 70.6%	312 75.7%	596 73.2%
Multiple-Black or African American and White	7 1.7%	5 1.2%	12 1.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Description	HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (Day -1) and Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	345	350
Least Squares Mean (Standard Error) [Percentage of glycosylated hemoglobin]	-1.04 (0.041)	-1.10 (0.040)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.05 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.

2. Secondary Outcome

Title	Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26
Description	Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
Measure Participants	402
Number [Participants]	218 54.2%

3. Secondary Outcome

Title	Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26
Description	Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Percentage of participants]	57.2 14.2%	75.0 18.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

4. Secondary Outcome

Title	Change From Baseline in Body Weight at Week 26
Description	Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (Day -1) and Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	349	352
Least Squares Mean (Standard Error) [Kilograms]	-1.95 (0.207)	2.43 (0.205)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.37
	Confidence Interval	(2-Sided) 95%; -4.93 to -3.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

5. Secondary Outcome

Title	Change From Baseline to Week 26 in Body Weight
Description	Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Baseline (Day -1) to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=368,384	-0.55 (0.091)	0.66 (0.091)
Week 5, n=382,393	-0.95 (0.102)	0.85 (0.102)
Week 10, n=379,397	-1.71 (0.133)	1.46 (0.131)
Week 18, n=365,372	-1.96 (0.177)	2.06 (0.175)
Week 26, n=349,352	-1.95 (0.207)	2.43 (0.205)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 95%; -1.43 to -1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 5
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.80
	Confidence Interval	(2-Sided) 95%; -2.05 to -1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.17
	Confidence Interval	(2-Sided) 95%; -3.51 to -2.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.01
	Confidence Interval	(2-Sided) 95%; -4.48 to -3.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.37
	Confidence Interval	(2-Sided) 95%; -4.93 to -3.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.

6. Secondary Outcome

Title	Total Daily Insulin Dose at Week 26
Description	Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	342	341
Least Squares Mean (Standard Error) [International Units]	70.36 (2.160)	131.19 (2.149)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-60.83
	Confidence Interval	(2-Sided) 95%; -66.57 to -55.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

7. Secondary Outcome

Title	Change From Baseline to Week 26 in HbA1c
Description	HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=358,375	-0.59 (0.023)	-0.47 (0.023)
Week 5, n=374,392	-0.67 (0.026)	-0.58 (0.025)
Week 10, n=376,390	-0.88 (0.034)	-0.96 (0.033)
Week 18, n=360,365	-1.04 (0.038)	-1.14 (0.038)
Week 26, n=345,350	-1.04 (0.041)	-1.1 (0.040)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Non-Inferiority
	Comments	Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95%; -0.18 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 5
	Type of Statistical Test	Non-Inferiority
	Comments	Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.15 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Non-Inferiority
	Comments	Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Non-Inferiority
	Comments	Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Non-Inferiority
	Comments	Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.05 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

8. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description	FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline and Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	345	349
Least Squares Mean (Standard Error) [Millimoles per Liter]	-2.01 (0.120)	-1.46 (0.121)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -0.86 to -0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

9. Secondary Outcome

Title	Change From Baseline to Week 26 in FPG
Description	FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

FA Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=356,371	-1.30 (0.119)	-0.76 (0.118)
Week 5, n=366,388	-1.07 (0.126)	-0.88 (0.125)
Week 18, n=348,353	-1.76 (0.124)	-1.23 (0.124)
Week 26, n=345,349	-2.01 (0.120)	-1.46 (0.121)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95%; -0.84 to -0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 5
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.53
	Confidence Interval	(2-Sided) 95%; -0.85 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -0.86 to -0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

10. Secondary Outcome

Title	Number of Participants Achieving HbA1c <7.0% at Week 26
Description	HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Participants]	244 60.7%	255 61.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7026
	Comments	Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

11. Secondary Outcome

Title	Number of Participants Achieving HbA1c <7.0% up to Week 26
Description	HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4	142 35.3%	139 33.7%
Week 5	157 39.1%	182 44.2%
Week 10	220 54.7%	261 63.3%
Week 18	251 62.4%	281 68.2%
Week 26	244 60.7%	255 61.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2883
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 5
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3034
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0151
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.52 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0518
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7026
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

12. Secondary Outcome

Title	Number of Participants Achieving a HbA1c <6.5% at Week 26
Description	Number of participants achieving a HbA1c <6.5% at Week 26 are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Participants]	147 36.6%	169 41%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2298
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

13. Secondary Outcome

Title	Number of Participants Achieving a HbA1c <6.5% up to Week 26
Description	Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4	39 9.7%	33 8%
Week 5	63 15.7%	62 15%
Week 10	116 28.9%	140 34%
Week 18	150 37.3%	178 43.2%
Week 26	147 36.6%	169 41%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2143
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.78 to 2.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 5
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4703
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2139
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.58 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0790
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2298
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

14. Secondary Outcome

Title	Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26
Description	Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Participants]	3 0.7%	3 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8292
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.24 to 4.77
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

15. Secondary Outcome

Title	Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26
Description	Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
0 to <=4 Weeks	0 0%	0 0%
>4 to <=5 Weeks	0 0%	0 0%
>5 to <=10 Weeks	2 0.5%	0 0%
>10 to <=18 Weeks	0 0%	1 0.2%
>18 to <=26 Weeks	1 0.2%	2 0.5%

16. Secondary Outcome

Title	Total Daily Insulin Dose at Week 4, Week 10 and Week 18
Description	Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Weeks 4, 10, and 18

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=388,403	50.53 (1.183)	106.91 (1.187)
Week 10, n=375,386	57.99 (1.597)	121.69 (1.589)
Week 18, n=359,361	68.23 (2.010)	130.22 (1.998)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-56.38
	Confidence Interval	(2-Sided) 95%; -59.19 to -53.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-63.70
	Confidence Interval	(2-Sided) 95%; -67.78 to -59.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-62.00
	Confidence Interval	(2-Sided) 95%; -67.29 to -56.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

17. Secondary Outcome

Title	Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits
Description	Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Weeks 4, 10, 18, and 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=388,403	49.97 (0.534)	50.94 (0.536)
Week 10, n=375,386	56.14 (0.767)	55.79 (0.761)
Week 18, n=359,361	59.42 (0.928)	59.18 (0.920)
Week 26, n=342,341	59.83 (0.996)	59.43 (0.988)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.97
	Confidence Interval	(2-Sided) 95%; -2.25 to 0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; -1.64 to 2.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95%; -2.21 to 2.69
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 26
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7699
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; -2.25 to 3.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

18. Secondary Outcome

Title	Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits
Description	Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Weeks 4, 10, 18, and 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Week 4, n=388,403	0.62 (0.887)	56.67 (0.892)
Week 10, n=375,386	1.90 (1.147)	66.66 (1.144)
Week 18, n=359,361	8.89 (1.436)	71.81 (1.430)
Week 26, n=342,341	10.64 (1.523)	72.47 (1.517)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-56.05
	Confidence Interval	(2-Sided) 95%; -58.17 to -53.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-64.76
	Confidence Interval	(2-Sided) 95%; -67.68 to -61.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	Week 18
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-62.92
	Confidence Interval	(2-Sided) 95%; -66.69 to -59.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments	week 26
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-61.83
	Confidence Interval	(2-Sided) 95%; -65.85 to -57.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.

19. Secondary Outcome

Title	Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26
Description	Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.
Time Frame	Baseline (Day -1) and Weeks 4, 10, 18 and 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Baseline, n=401,412	28.79 (1.470)	28.00 (0.000)
Week 4, n=388,403	8.11 (1.506)	28.00 (0.000)
Week 10, n=375,386	9.06 (3.121)	28.00 (0.000)
Week 18, n=359,361	12.62 (7.330)	28.00 (0.000)
Week 26, n=342,341	13.22 (7.758)	28.00 (0.000)

20. Secondary Outcome

Title	Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26
Description	Percentage of participants achieving HbA1c <7.0% without weight gain are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Percentage of participants]	49.8 12.4%	21.4 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.50
	Confidence Interval	(2-Sided) 95%; 2.52 to 4.86
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

21. Secondary Outcome

Title	Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26
Description	Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Percentage of participants]	21.1 5.2%	9.5 2.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.36
	Confidence Interval	(2-Sided) 95%; 1.54 to 3.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

22. Secondary Outcome

Title	Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26
Description	Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

FA Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	402	412
Number [Percentage of participants]	15.9 4%	3.9 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.78
	Confidence Interval	(2-Sided) 95%; 2.21 to 6.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.

23. Secondary Outcome

Title	Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication
Description	AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
AE	261 64.9%	254 61.7%
SAE	23 5.7%	31 7.5%
AE leading to study medication discontinuation	12 3%	6 1.5%

24. Secondary Outcome

Title	Number of Participants With Other AE of Special Interest
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Hypoglycemic Events	305 75.9%	361 87.6%
Cardiovascular Events	7 1.7%	9 2.2%
Gastrointestinal Events	102 25.4%	53 12.9%
Injection Site Reactions	8 2%	1 0.2%
Systemic Allergic Reactions	3 0.7%	0 0%
Pancreatitis	1 0.2%	0 0%
Pancreatic cancer	0 0%	0 0%
Malignant Neoplasm	2 0.5%	2 0.5%
Diabetic Retinopathy	4 1%	17 4.1%
Appendicitis	1 0.2%	0 0%
Liver Events	0 0%	2 0.5%
Pneumonia	1 0.2%	3 0.7%
Atrial Fibrillation/Flutter	4 1%	1 0.2%

25. Secondary Outcome

Title	Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26
Description	Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Any event: Onset date falls under 0 to <= 12 weeks	55.3 13.8%	79.2 19.2%
Any event: Onset date falls > 12 to <= 26 Weeks	60.3 15%	79.4 19.3%
Severe: Onset date falls under 0 to <= 12 weeks	1.8 0.4%	3.6 0.9%
Severe: Onset date falls > 12 to <= 26 Weeks	0.8 0.2%	1.9 0.5%
DS: Onset date falls under 0 to <= 12 weeks	33.8 8.4%	63.0 15.3%
DS: Onset date falls > 12 to <= 26 Weeks	40.8 10.1%	62.0 15%
Asymptomatic: Onset date under 0 to <= 12 weeks	38.3 9.5%	56.9 13.8%
Asymptomatic: Onset date falls > 12 to <= 26 Weeks	44.3 11%	54.7 13.3%

26. Secondary Outcome

Title	Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)
Description	The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Severe	9 2.2%	22 5.3%
Documented Symptomatic	203 50.5%	299 72.6%
Asymptomatic	230 57.2%	293 71.1%
Probably Symptomatic	29 7.2%	52 12.6%
Pseudohypoglycemia	45 11.2%	83 20.1%
Missing	9 2.2%	13 3.2%
Total	305 75.9%	361 87.6%

27. Secondary Outcome

Title	Number of Participants With Daytime and Nocturnal Hypoglycemia
Description	Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Any (Total) Daytime Hypoglycemic Event	288 71.6%	356 86.4%
Any (Total) Nocturnal Hypoglycemic Event	155 38.6%	225 54.6%
Severe Daytime Hypoglycemic Event	6 1.5%	14 3.4%
Severe Nocturnal Hypoglycemic Event	4 1%	6 1.5%
Documented Symptomatic Daytime Hypoglycemic event	187 46.5%	293 71.1%
Documented Symptomatic Nocturnal Hypoglycemia	101 25.1%	152 36.9%
Asymptomatic Daytime Hypoglycemic event	217 54%	281 68.2%
Asymptomatic Nocturnal Hypoglycemic event	77 19.2%	106 25.7%
Probably Symptomatic Daytime Hypoglycemic event	22 5.5%	44 10.7%
Probably Symptomatic Nocturnal Hypoglycemic event	7 1.7%	21 5.1%
Pseudohypoglycemia Daytime Hypoglycemic event	36 9%	70 17%
Pseudohypoglycemia Nocturnal Hypoglycemic event	17 4.2%	34 8.3%
Missing Daytime Hypoglycemic Event	9 2.2%	11 2.7%
Mising Nocturnal Hypoglycemic Event	2 0.5%	4 1%

28. Secondary Outcome

Title	Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms
Description	Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.
Time Frame	Up to Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Number [Participants]	141 35.1%	239 58%

29. Secondary Outcome

Title	Number of Participants With Hematology Values of Clinical Concern
Description	Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.
Time Frame	Up to 30 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	394	407
Hematocrit: >0.05 (fraction) below LLN	5 1.2%	6 1.5%
Hematocrit: >0.04 (fraction) above ULN	9 2.2%	12 2.9%
Hemoglobin: >20 g/L below LLN	9 2.2%	9 2.2%
Hemoglobin: >10 g/L above ULN	2 0.5%	3 0.7%
Leukocytes: >1 GI/L below LLN	1 0.2%	1 0.2%
Leukocytes: >5 GI/L above ULN	4 1%	1 0.2%
Neutrophils: <1 GI/L	2 0.5%	3 0.7%
Neutrophils, Segmented: <0.5 x LLN	2 0.5%	3 0.7%
Platelets: <80 GI/L	1 0.2%	1 0.2%
Platelets: >500 GI/L	3 0.7%	1 0.2%

30. Secondary Outcome

Title	Number of Participants With Clinical Chemistry Values of Clinical Concern
Description	Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.
Time Frame	Up to 30 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Fasting Serum Glucose: <3 mmol/L, n= 394,405	12 3%	16 3.9%
Fasting Serum Glucose: >22 mmol/L, n= 394,405	0 0%	1 0.2%
Fasting Plasma Glucose: <3 mmol/L, n= 388,406	9 2.2%	14 3.4%
Fasting Plasma Glucose: >22 mmol/L, n= 388,406	1 0.2%	0 0%
Albumin: >5 g/L below LLN, n=394,407	0 0%	0 0%
Albumin: >5 g/L above ULN, n=394,407	0 0%	0 0%
Calcium: <1.8 mmol/L, n=394,407	1 0.2%	1 0.2%
Calcium: >3.0 mmol/L, n=394,407	0 0%	0 0%
Carbon Dioxide: <16 mmol/L, n=394,407	5 1.2%	8 1.9%
Carbon Dioxide: >40 mmol/L, n=394,407	0 0%	0 0%
Magnesium: <0.411 mmol/L, n=394,407	1 0.2%	1 0.2%
Magnesium: >1.644 mmol/L, n=394,407	0 0%	0 0%
Phosphate: >0.323 mmol/L below LLN, n=394,407	0 0%	0 0%
Phosphate: >0.323 mmol/L above ULN, n=394,407	2 0.5%	4 1%
Potassium: >0.5 mmol/L below LLN, n=394,407	1 0.2%	0 0%
Potassium: >1.0 mmol/L above ULN, n=394,407	0 0%	1 0.2%
Protein: >15 g/L below LLN, n=394,407	0 0%	0 0%
Protein: >15 g/L above ULN, n=394,407	0 0%	0 0%
Sodium: >5 mmol/L below LLN, n=394,407	1 0.2%	0 0%
Sodium: >5 mmol/L above ULN, n=394,407	1 0.2%	0 0%
Triglycerides: >9.04 mmol/L, n=393,405	7 1.7%	1 0.2%
Urate: >654 μmol/L, n=394,407	0 0%	2 0.5%
Urea: >2 x ULN, n=394,407	2 0.5%	1 0.2%
Alanine Aminotransferase: >3 x ULN, n=396,410	0 0%	5 1.2%
Alkaline Phosphatase: >3 x ULN, n=396,410	1 0.2%	0 0%
Aspartate Aminotransferase: >3 x ULN, n=396,410	0 0%	2 0.5%
Bilirubin: >1.5 x ULN, n=396,410	1 0.2%	1 0.2%
Creatinine: >159 μmol/L, n=396,410	20 5%	16 3.9%
Direct Bilirubin: >1.35 x ULN, n=396,410	0 0%	1 0.2%
Gamma Glutamyl Transferase: >3 x ULN, n=396,410	14 3.5%	14 3.4%

31. Secondary Outcome

Title	Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26
Description	Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Week 0, n=369,376	14.40 (49.884)	11.57 (31.089)
Week 26, n=317,324	10.37 (32.992)	11.55 (31.975)

32. Secondary Outcome

Title	Mean Albumin at Week 0 and Week 26
Description	Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Week 0, n=394,405	127.7 (428.46)	108.2 (301.88)
Week 26, n=348,345	110.5 (375.41)	146.3 (628.73)

33. Secondary Outcome

Title	Mean Creatinine at Week 0 and Week 26
Description	Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Week 0, n=395,406	10646.3 (5190.43)	10663.8 (5639.54)
Week 26, n=350,345	11364.6 (5998.72)	11394.2 (5663.72)

34. Secondary Outcome

Title	Mean Specific Gravity at Week 0 and Week 26
Description	Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
Week 0, n=388,402	1.0182 (0.00599)	1.0180 (0.00588)
Week 26, n=347,343	1.0180 (0.00627)	1.0186 (0.00588)

35. Secondary Outcome

Title	Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26
Description	Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
pH=5; Week 0, n=388,402	92 22.9%	107 26%
pH=5.5; Week 0, n=388,402	132 32.8%	132 32%
pH=6; Week 0, n=388,402	86 21.4%	77 18.7%
pH=6.5; Week 0, n=388,402	29 7.2%	43 10.4%
pH=7; Week 0, n=388,402	29 7.2%	24 5.8%
pH=7.5; Week 0, n=388,402	13 3.2%	11 2.7%
pH=8; Week 0, n=388,402	6 1.5%	7 1.7%
pH=8.5; Week 0, n=388,402	1 0.2%	1 0.2%
pH=5; Week 26, n=347,343	80 19.9%	100 24.3%
pH=5.5; Week 26, n=347,343	107 26.6%	104 25.2%
pH=6; Week 26, n=347,343	69 17.2%	70 17%
pH=6.5; Week 26, n=347,343	42 10.4%	23 5.6%
pH=7; Week 26, n=347,343	19 4.7%	23 5.6%
pH=7.5; Week 26, n=347,343	17 4.2%	18 4.4%
pH=8; Week 26, n=347,343	7 1.7%	5 1.2%
pH=8.5; Week 26, n=347,343	5 1.2%	0 0%
pH>9; Week 26, n=347,343	1 0.2%	0 0%

36. Secondary Outcome

Title	Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26
Description	Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
None Seen; Week 0, n=171,187	119 29.6%	101 24.5%
0 to 1; Week 0, n=171,187	34 8.5%	51 12.4%
1 to 3; Week 0, n=171,187	9 2.2%	14 3.4%
3 to 5; Week 0, n=171,187	3 0.7%	12 2.9%
5 to 10; Week 0, n=171,187	2 0.5%	4 1%
10 to 15; Week 0, n=171,187	0 0%	2 0.5%
15 to 25; Week 0, n=171,187	2 0.5%	1 0.2%
50 to 100; Week 0, n=171,187	0 0%	1 0.2%
>100; Week 0, n=171,187	2 0.5%	1 0.2%
None Seen; Week 26, n=166,144	98 24.4%	79 19.2%
0 to 1; Week 26, n=166,144	48 11.9%	36 8.7%
1 to 3; Week 26, n=166,144	8 2%	19 4.6%
3 to 5; Week 26, n=166,144	4 1%	3 0.7%
5 to 10; Week 26, n=166,144	4 1%	4 1%
25 to 50; Week 26, n=166,144	1 0.2%	2 0.5%
50 to 100; Week 26, n=166,144	2 0.5%	0 0%
>100; Week 26, n=166,144	1 0.2%	1 0.2%

37. Secondary Outcome

Title	Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26
Description	Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.
Time Frame	Week 0 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
None Seen; Week 0, n=171,187	69 17.2%	67 16.3%
0 to 1; Week 0, n=171,187	27 6.7%	31 7.5%
1 to 3; Week 0, n=171,187	20 5%	18 4.4%
3 to 5; Week 0, n=171,187	16 4%	13 3.2%
5 to 10; Week 0, n=171,187	17 4.2%	19 4.6%
10 to 15; Week 0, n=171,187	7 1.7%	6 1.5%
15 to 25; Week 0, n=171,187	5 1.2%	11 2.7%
25 to 50; Week 0, n=171,187	5 1.2%	11 2.7%
50 to 100; Week 0, n=171,187	1 0.2%	7 1.7%
>100; Week 0, n=171,187	4 1%	3 0.7%
Innumerable; Week 0, n=171,187	0 0%	1 0.2%
None Seen; Week 26, n=166,144	65 16.2%	44 10.7%
0 to 1; Week 26, n=166,144	25 6.2%	29 7%
1 to 3; Week 26, n=166,144	22 5.5%	20 4.9%
3 to 5; Week 26, n=166,144	10 2.5%	15 3.6%
5 to 10; Week 26, n=166,144	22 5.5%	14 3.4%
10 to 15; Week 26, n=166,144	8 2%	5 1.2%
15 to 25; Week 26, n=166,144	3 0.7%	3 0.7%
20 to 50; Week 26, n=166,144	0 0%	1 0.2%
25 to 50; Week 26, n=166,144	5 1.2%	6 1.5%
50 to 100; Week 26, n=166,144	5 1.2%	5 1.2%
>100; Week 26, n=166,144	1 0.2%	1 0.2%
Innumerable; Week 26, n=166,144	0 0%	1 0.2%

38. Secondary Outcome

Title	Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26
Description	Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame	Baseline, Week 10 and Week 26

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	400	413
TC: Week 10, n=376,393	-0.244 (0.8047)	0.041 (0.7425)
TC: Week 26, n=348,351	-0.059 (0.8721)	0.073 (0.8232)
HDL-c: Week 10, n=376,393	-0.041 (0.1944)	0.016 (0.1810)
HDL-c: Week 26, n=348,351	-0.013 (0.2102)	0.005 (0.2138)
TG: Week 10, n=376,393	-0.039 (1.3563)	-0.065 (0.8045)
TG: Week 26, n=348,351	0.025 (1.1949)	-0.028 (0.9342)

39. Secondary Outcome

Title	Number of Participants With Vital Signs of Clinical Concern
Description	Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.
Time Frame	Up to 30 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	397	411
SBP: < 100 mmHg	21 5.2%	20 4.9%
SBP: > 170 mmHg	27 6.7%	30 7.3%
DBP: < 50 mmHg	1 0.2%	4 1%
DBP: > 110 mmHg	1 0.2%	5 1.2%
Pulse Rate: < 50 bpm	4 1%	9 2.2%
Pulse Rate: > 120 bpm	3 0.7%	1 0.2%

40. Secondary Outcome

Title	Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
Description	A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.
Time Frame	Up to 30 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Albiglutide + Insulin Glargine	Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Measure Participants	384	394
Clinically Significant Change: Favorable	18 4.5%	9 2.2%
Clinically Significant Change: Unfavorable	4 1%	5 1.2%

Adverse Events

Time Frame	Up to 26 weeks
Adverse Event Reporting Description	On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Arm/Group Title	Albiglutide + Insulin Glargine		Insulin Lispro + Insulin Glargine
Arm/Group Description	During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.		During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
All Cause Mortality
	Albiglutide + Insulin Glargine		Insulin Lispro + Insulin Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/400 (0%)		1/413 (0.2%)
Serious Adverse Events
	Albiglutide + Insulin Glargine		Insulin Lispro + Insulin Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/400 (5.8%)		31/413 (7.5%)
Cardiac disorders
Acute myocardial infarction	1/400 (0.3%)	1	2/413 (0.5%)	2
Angina unstable	1/400 (0.3%)	2	1/413 (0.2%)	1
Angina pectoris	0/400 (0%)	0	1/413 (0.2%)	1
Atrial fibrillation	0/400 (0%)	0	1/413 (0.2%)	2
Atrial flutter	1/400 (0.3%)	2	0/413 (0%)	0
Atrioventricular block complete	1/400 (0.3%)	1	0/413 (0%)	0
Cardiac failure congestive	0/400 (0%)	0	1/413 (0.2%)	1
Ear and labyrinth disorders
Conductive deafness	1/400 (0.3%)	1	0/413 (0%)	0
Vertigo positional	1/400 (0.3%)	1	0/413 (0%)	0
Eye disorders
Angle closure glaucoma	1/400 (0.3%)	1	0/413 (0%)	0
Gastrointestinal disorders
Colitis	0/400 (0%)	0	1/413 (0.2%)	1
Mesenteric artery stenosis	1/400 (0.3%)	1	0/413 (0%)	0
Pancreatitis	1/400 (0.3%)	1	0/413 (0%)	0
Rectal haemorrhage	0/400 (0%)	0	1/413 (0.2%)	1
General disorders
Chest pain	1/400 (0.3%)	1	0/413 (0%)	0
Non-cardiac chest pain	0/400 (0%)	0	1/413 (0.2%)	1
Hepatobiliary disorders
Cholecystitis acute	0/400 (0%)	0	1/413 (0.2%)	1
Infections and infestations
Pneumonia	1/400 (0.3%)	1	2/413 (0.5%)	2
Osteomyelitis	0/400 (0%)	0	2/413 (0.5%)	2
Appendicitis	1/400 (0.3%)	1	0/413 (0%)	0
Gastroenteritis	1/400 (0.3%)	1	0/413 (0%)	0
Influenza	1/400 (0.3%)	1	0/413 (0%)	0
Pyelonephritis	1/400 (0.3%)	1	0/413 (0%)	0
Injury, poisoning and procedural complications
Ligament injury	0/400 (0%)	0	1/413 (0.2%)	1
Multiple injuries	1/400 (0.3%)	1	0/413 (0%)	0
Perineal injury	0/400 (0%)	0	1/413 (0.2%)	1
Thoracic vertebral fracture	1/400 (0.3%)	1	0/413 (0%)	0
Metabolism and nutrition disorders
Hypoglycaemia	0/400 (0%)	0	6/413 (1.5%)	6
Diabetes mellitus	0/400 (0%)	0	1/413 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	0/400 (0%)	0	1/413 (0.2%)	1
Breast cancer	0/400 (0%)	0	1/413 (0.2%)	1
Teratoma	1/400 (0.3%)	1	0/413 (0%)	0
Nervous system disorders
Syncope	1/400 (0.3%)	1	1/413 (0.2%)	1
Brain stem infarction	0/400 (0%)	0	1/413 (0.2%)	1
Carpal tunnel syndrome	0/400 (0%)	0	1/413 (0.2%)	1
Cerebrovascular accident	0/400 (0%)	0	1/413 (0.2%)	1
Facial paralysis	1/400 (0.3%)	1	0/413 (0%)	0
Hyperaesthesia	1/400 (0.3%)	1	0/413 (0%)	0
Ischaemic stroke	0/400 (0%)	0	1/413 (0.2%)	1
Sciatica	1/400 (0.3%)	1	0/413 (0%)	0
Transient ischaemic attack	0/400 (0%)	0	1/413 (0.2%)	1
Renal and urinary disorders
Acute kidney injury	1/400 (0.3%)	1	0/413 (0%)	0
Reproductive system and breast disorders
Metrorrhagia	0/400 (0%)	0	1/413 (0.2%)	1
Uterine polyp	1/400 (0.3%)	1	0/413 (0%)	0
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	1/400 (0.3%)	1	0/413 (0%)	0
Vascular disorders
Peripheral ischaemia	1/400 (0.3%)	1	1/413 (0.2%)	1
Hypertensive crisis	0/400 (0%)	0	1/413 (0.2%)	1
Peripheral arterial occlusive disease	1/400 (0.3%)	1	0/413 (0%)	0
Peripheral artery stenosis	0/400 (0%)	0	1/413 (0.2%)	1
Peripheral vascular disorder	1/400 (0.3%)	1	0/413 (0%)	0
Other (Not Including Serious) Adverse Events
	Albiglutide + Insulin Glargine		Insulin Lispro + Insulin Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	114/400 (28.5%)		101/413 (24.5%)
Gastrointestinal disorders
Diarrhoea	31/400 (7.8%)	51	18/413 (4.4%)	19
Nausea	37/400 (9.3%)	53	7/413 (1.7%)	7
Infections and infestations
Influenza	24/400 (6%)	30	36/413 (8.7%)	42
Viral upper respiratory tract infection	25/400 (6.3%)	33	34/413 (8.2%)	39
Urinary tract infection	22/400 (5.5%)	25	23/413 (5.6%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.